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Simultaneous Coronary Artery Evaluation and Lung Cancer CT Screening

Simultaneous Coronary Artery Evaluation and Lung Cancer Screening With a New Ultrafast-low-dose Computed Tomography Protocol: A Pilot Randomized Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03727958
Acronym
SIMULTANEOUS
Enrollment
100
Registered
2018-11-01
Start date
2018-11-01
Completion date
2018-12-31
Last updated
2018-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HEAVY SMOKING

Brief summary

Cardiac computed tomography (CT) is often performed in patients who are at high risk for lung cancer in whom screening is currently recommended. This pilot randomized study will test the feasibility, safety and diagnostic ability of a novel ultra-low-dose CT protocol that allows concomitant coronary artery evaluation and lung screening. Current or former heavy smoker subjects with suspected or known coronary artery disease will be randomized to undergo CT assessment of either thoracic area only or both coronary arteries and thoracic area. Primary end-points will be the effective contrast and radiation doses.

Detailed description

Cardiac computed tomography (CT) scan is an ideal diagnostic tool for identifying coronary artery disease in patients with low or intermediate risk. In recent years, cardiac CT is being often performed in patients who are at high risk either for coronary artery disease or lung cancer. The update edition of the National Institute for Health and Care Excellence (NICE) guidelines recommends cardiac CT as the first-line diagnostic tool for patients with new-onset chest pain due to suspected coronary artery disease. Also, symptomatic patients with known coronary artery disease and previous percutaneous coronary intervention who have an unclear stress test but whose presentation suggests a high likelihood of having an in-stent restenosis or a 'de novo' stenosis might benefit from cardiac CT. In 2014, the U.S. Preventive Services Task Force recommended annual lung cancer screening with ultra-low dose computed tomography for current and former heavy smokers aged 55 to 80 years. Indeed, lung cancer screening in patients with suspected or known coronary artery disease undergoing cardiac CT may provide the opportunity to implement recommendation for lung cancer screening in clinical practice.This pilot randomized study will test the feasibility, safety and diagnostic ability of a novel ultra-low-dose CT protocol that allows concomitant coronary artery evaluation and lung screening. Current or former heavy smoker subjects with suspected or known coronary artery disease will be randomized to undergo CT assessment of either thoracic area only or both coronary arteries and thoracic area. Primary end-points will be the effective contrast and radiation doses.

Interventions

DIAGNOSTIC_TESTLung and coronary CT assessment

Subjects will undergo simultaneous coronary arteries and thoracic CT assessment

DIAGNOSTIC_TESTCoronary CT assessment

Subjects will undergo coronary arteries CT assessment only

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Current or former heavy smoker subjects with suspected or known coronary artery disease will be randomized to undergo CT assessment of both coronary arteries and thoracic area for simultaneous coronary artery and lung cancer screening

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Symptomatic subjects with effort-induced or typical chest pain * High probability of coronary artery disease * Known coronary artery disease * Willing to participate to the study * Informed consent to undergo CT scan

Exclusion criteria

* Contraindications to iodinated contrast such as allergies and chronic kidney failure * Any suspicion of pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Safety of computed tomography as measured by effective radiation dose (as measured in mSv)Through study completion, an average of 2 monthsMeasurement of the effective radiation dose (as measured in mSv) at time of computed tomography

Contacts

Primary ContactFrancesco Pelliccia, MD
f.pelliccia@mclink.it+390633062615
Backup ContactFrancesco Gaudio, MD
f.pelliccia@mclink.it+390633062615

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026